BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEAD MODEL 302

    MDR report key: 1181367 · Received September 23, 2008

    Report

    Report Number
    1644487-2008-02291
    Event Type
    Malfunction
    Date Received
    September 23, 2008
    Date of Event
    January 1, 2008
    Report Date
    August 25, 2008
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE FAILURE IS SUSPECTED, BUT DID NOT CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A LEAD BREAK WAS DISCOVERED DURING A PROPHYLACTIC GENERATOR REPLACEMENT SURGERY. THE PORTIONS OF THE LEAD THAT WERE REMOVED DURING SURGERY WERE DISCARDED IN THE OR AND WILL NOT BE RETURNING TO THE MANUFACTURER FOR ANALYSIS. GOOD FAITH ATTEMPTS TO OBTAIN INFO ON THE SUSPECTED CAUSE OF THE LEAD BREAK HAVE BEEN UNSUCCESSFUL TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LEAD MODEL 302 LYJ CYBERONICS, INC. 302-20 9771

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR